'/%3e%3cg%20fill='%230A2540'%3e%3ccircle%20cx='725'%20cy='280'%20r='72'/%3e%3ccircle%20cx='705'%20cy='754'%20r='72'/%3e%3c/g%3e%3c/svg%3e)
About AI Health Central
A structured repository for AI medical device regulation.
AI Health Central helps teams navigate the regulations, standards, and policy updates shaping AI-enabled medical software — brought together from official primary sources, organised by country and topic, and kept current.
What it is
One place for the regulatory record on AI medical software.
AI Health Central is a structured resource platform for professionals working at the intersection of artificial intelligence, medical software, regulation, and product development. It brings together regulatory, standards, and policy resources from official authorities worldwide.
The focus is intentionally narrow: regulated AI clinical software. General digital health resources are not included unless directly relevant to AI medical devices.
Why it exists
AI medical device regulation is fragmented.
Fragmented sources.
Relevant information is spread across regulators, health authorities, standards bodies, and policy institutions. AI Health Central brings these resources together.
Hard to track.
Guidance is updated, frameworks are revised, and new jurisdictions publish expectations. Staying current across all of them manually is not practical.
One structured view.
Organised by country, topic, and document type — searchable and kept current so teams can find what applies to their work.
Platform modules
Three entry points into the AI medical device landscape.
Regulatory Map
Explore AI medical device regulations, guidance documents, policy frameworks, and institutional resources by country and region.
AI Radar
Track regulatory, policy, and institutional updates related to medical AI, AI-enabled software, and healthcare AI oversight.
RegStandards
Access key ISO, IEC, and international standards supporting AI medical device development and software compliance.
Who it's for
Built for teams developing AI-enabled medical software.
QA / RA Teams
Monitor regulatory expectations and guidance across key jurisdictions.
Compliance Teams
Track frameworks, standards, and governance resources relevant to medical AI.
Product Teams
Understand regulatory and standards considerations earlier in development.
Founders & Operators
Navigate the requirements shaping AI medical device development and scale-up.
Focus
A focused set of topics within regulated AI clinical software.
AI Health Central covers AI/ML in medical devices, software as a medical device, clinical decision support, radiology and imaging AI, cybersecurity, Predetermined Change Control Plans, and AI governance.
General digital health resources are not included unless directly relevant to AI medical devices.
Leadership
Explore the repository.
Browse the regulatory map, follow the radar, and access the standards that shape AI medical device development.
AI Health Central is a curated repository of publicly available regulatory and standards information. It does not constitute legal, regulatory, or medical advice.